Key Regulatory Developments for our clients: EUDAMED, MDR Transition, and Upcoming EU Changes
The European MedTech regulatory landscape continues to evolve in Q1 2026, with several developments that require immediate attention from manufacturers, authorized representatives, and other economic operators.
From the upcoming mandatory use of EUDAMED modules to ongoing MDR transition requirements and potential legislative changes, companies are expected to move from awareness to structured implementation.
EUDAMED Mandatory Use Approaching
The first four EUDAMED modules are now on a confirmed path towards mandatory use from 28 May 2026. According to the European Commission, this includes:
- Actor Registration
- UDI/Device Registration
- Notified Bodies and Certificates
- Market Surveillance
Although the initial announcement was published in late November 2025, its relevance has increased throughout Q1 2026 as timelines become operational rather than theoretical. For MedTech companies, this marks a clear transition from a partially optional system to mandatory utilization of core EUDAMED functionalities.
In practical terms, organizations should now focus on:
- Finalizing registration readiness
- Defining internal ownership and responsibilities
- Strengthening UDI data governance processes
- Aligning certificate and post-market surveillance workflows
- Companies that delay these steps risk operational bottlenecks as the deadline approaches.
Kalms Consulting supports organizations in understanding their specific EUDAMED obligations, preparing for upcoming deadlines, and managing the registration process in a structured and practical way.
MDR/IVDR Transition Planning Remains a Priority
The impact of Regulation (EU) 2023/607 continues to shape regulatory strategy in Q1 2026. While the extension of MDR transition timelines has reduced immediate pressure, it has not removed the underlying compliance requirements.
Instead, the focus is shifting towards structured transition planning and execution.
As the 2027, 2028 and 2029 deadlines approach, manufacturers should:
- Reassess portfolio transition strategies
- Confirm notified body capacity and agreements
- Continue remediation of technical documentation
- Align regulatory timelines with commercial priorities
The most prepared organizations are those treating the extension as a strategic window for implementation rather than a reason to delay action.
Kalms Consulting supports manufacturers throughout the transition from MDD/IVDD to MDR/IVDR, helping to structure the process, priorities activities, and align regulatory requirements with broader business objectives.
European Commission Proposal May Reshape MDR and IVDR Implementation
Another important development is the European Commission proposal published on 16 December 2025, aiming to amend the MDR and IVDR frameworks.
The initiative focuses on:
- Simplifying administrative processes
- Reducing regulatory burden
- Improving predictability
- Supporting continued availability of safe medical devices
- Proposed measures may include:
- Adjustments to device classification
- Increased digitalization
- Streamlined clinical and performance evidence expectations
- More flexible certification pathways
If adopted, these changes could significantly impact conformity assessment processes, documentation requirements, timelines, and cost structures. At the same time, stakeholder feedback suggests that the outcome will depend heavily on the legislative process and how specific provisions are defined. For manufacturers, this reinforces the need for flexible regulatory planning and continuous portfolio assessment.
Kalms Consulting can support companies in evaluating how proposed MDR and IVDR changes may affect their regulatory strategy, documentation requirements, and market positioning.
Strategic Takeaway
Across all three developments, a common theme emerges:
Regulatory compliance in the EU is becoming more structured, data-driven, and operationally demanding. Companies that invest early in preparation, internal alignment, and structured processes will be significantly better positioned to manage both current requirements and future changes.
How Kalms Consulting Supports Your Regulatory Strategy
Navigating EUDAMED implementation, MDR transition planning, and upcoming regulatory changes requires more than theoretical understanding. It requires structured execution, clear prioritization, and alignment between regulatory, operational, and commercial teams.
Kalms Consulting supports MedTech and digital health companies across all three areas. From EUDAMED readiness and registration processes, through MDR transition strategy and technical documentation planning, to assessing the impact of upcoming MDR and IVDR changes, we provide practical, hands-on support tailored to your organization.
Our approach focuses on translating regulatory requirements into actionable steps, helping you reduce complexity, avoid delays, and maintain market access across the European Union.
If you are currently assessing your regulatory roadmap or preparing for upcoming deadlines, our team is available to support you with a structured and efficient approach.
Bibliography
European Commission (2025). EUDAMED: Four first modules will be mandatory from 28 May 2026. Available at: https://health.ec.europa.eu/latest-updates/eudamed-four-first-modules-will-be-mandatory-use-28-may-2026-2025-11-27_
EUR-Lex (2023). Regulation (EU) 2023/607. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32023R0607
European Commission (2025). Proposal for a regulation to simplify rules for medical and in vitro diagnostic devices. Available at: https://health.ec.europa.eu/publications/proposal-regulation-simplify-rules-medical-and-vitro-diagnostic-devices_en
Published on: April 8, 2026
